The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial, called "The Gut-Brain Axis During Neurorehabilitation," is exploring how the gut bacteria of patients with brain injuries may be linked to their recovery, particularly looking at fatigue and thinking abilities. Researchers want to see if a special dietary fiber called Inulin can change the gut bacteria and improve these symptoms in patients undergoing rehabilitation at Moody Neurorehabilitation Institute. The study is currently recruiting participants who are at least 18 years old, have suffered a brain injury within the last six months, and are able to eat and drink by mouth.

Participants in the trial can expect to be part of a study that examines both their gut health and their recovery process. They will be compared to a control group of community members who have a family member at the rehabilitation center. It's important to note that certain medical conditions may exclude individuals from participating, such as significant heart or liver diseases, and a history of certain gastrointestinal issues. If you or a loved one is interested in this study, please check with the research team to see if the eligibility criteria are met.

Gender

ALL

Eligibility criteria

• • Brain Injury Patients
• • Inclusion
• • Ages 18 and above
• • Admitted to Moody Neurorehabilitation Institute for care
• • Less than 6 months post-injury
• • English speaking
• • Must be able to eat and drink by mouth
• • Willing and able to comply with study procedures
• • Willing and able to provide consent (with LAR if needed)
• • Exclusion
• • Significant heart, liver, kidney, blood or respiratory disease
• • HIV, Hepatitis B or Hepatitis C
• • Pregnancy or becoming pregnant during the study
• • History of inflammatory bowel disease
• • History of celiac disease
• • Active diverticular disease
• • Known allergy to study agent
• • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
• • Community Control Subjects
• • Inclusion
• • Ages 18 and above
• • Have a family member who is admitted to Moody Neurorehabilitation Institute for care OR is working at Moody Neurorehabilitation Institute
• • English speaking
• • Willing and able to comply with study procedures
• • Willing and able to provide consent
• • FACs score ≤ 50
• • Exclusion
• • Trauma to head in last 6 months
• • Stroke in last 6 months
• • Significant heart, liver, kidney, blood or respiratory disease
• • HIV, Hepatitis B or Hepatitis C
• • Pregnancy or becoming pregnant during the study
• • History of inflammatory bowel disease
• • History of celiac disease
• • Active diverticular disease
• • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation